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NCT Number: NCT02384980

Saving Life and Limb: FES for the Elderly With PAD

This study will take the first step to improve public health for millions of Americans with Peripheral Arterial Disease who have extreme difficulty walking due to leg pain. The investigators will assess a proof of concept, home administered, functional electrical stimulation (FES) system to resolve pain, improve walking, and enhance quality of life.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MultiCare Health System

Tacoma, Washington, 98405, United States

About this study

This study will evaluate an innovative approach to reduce the debilitating symptoms of peripheral arterial disease (PAD) and ischemic pain during walking (intermittent claudication) by using a new Functional Electrical Stimulation (FES) system. The investigators hypothesize that combining the FES and walking one hour/day (FES+Walk) will significantly reduce pain during walking, improve locomotion, and enhance quality of life when compared to walking one hour/day (Walk) alone after 8 weeks of intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who:

  • Are ambulatory, community dwelling adults with evidence of PAD including ankle/brachial index ABI=0.4-0.9
  • Have symptom severity of Fontaine stage II-III
  • Have a score of 24 or higher on the Folstein Mini Mental test
  • Have visible muscle contraction of the plantar flexor (PF) and dorsiflexor (DF) muscles using FES

Exclusion criteria

Patients who:

  • Have an electronic implanted stimulator such as pacemaker, defibrillator, deep brain stimulator, spinal cord stimulator
  • Are pregnant
  • Cannot walk without a walker or require human assistance to walk,
  • Present with arthritis or neurological damage resulting in paresis or paralysis of the lower extremity
  • Have skin lesion(s) on the legs where the FES is placed

Treatment and study plan

FES (Gait MyoElectric Stimulator)

Device

Functional Electrical Stimulation (FES) will be tested in a group of peripheral arterial disease patients using the Gait MyoElectric Stimulator. The FES device will be applied to the calf and shin muscles on both of the patients legs.

Primary outcomes

  1. Change from initial assessment, baseline, end of intervention and final assessment using the Perceived Pain Intensity Scale

    Time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post-intervention)

    We will measure the changes in pain scores from baseline to end of intervention and end of post-intervention

  2. Change from initial assessment, baseline, end of intervention and final assessment using the 6 Minute Walk Test

    Time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention, and final assessment at 16 weeks (8 weeks post- intervention)

    We will measure the changes in distance walked during the 6 minute walk test

  3. Change from initial assessment, baseline, end of intervention and final assessment using the Peripheral Artery Disease Quality of Life Questionnaire

    Time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention)

    We will record and measure the changes in questionnaire scores from baseline to end of intervention and end of post-intervention

Secondary outcomes

  1. Change from initial assessment, baseline, end of intervention and final assessment using the Timed-Up-and-Go test

    Time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention)

    We will measure the time (seconds) to complete the test from baseline to end of intervention and end of post-intervention

  2. Change from initial assessment, baseline, end of intervention and final assessment using the Intermittent Claudication Questionnaire (ICQ)

    Time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention)

    We will record and measure the questionnaire score from baseline to end of intervention and end of post-intervention

Sponsors and collaborators

Lead sponsor

MultiCare Health System Research Institute

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Saving Life and Limb: Functional Electrical Stimulation for the Elderly With Peripheral Artery Disease

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 10, 2015
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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